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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K100425
Device Name HASKAL TORQUE DEVICE
Applicant
Elcam Medical Acal
Kibbutz Bar-Am
Mp. Merom Hagalil,  IL 13860
Applicant Contact SHAY SHAHAM
Correspondent
Elcam Medical Acal
Kibbutz Bar-Am
Mp. Merom Hagalil,  IL 13860
Correspondent Contact SHAY SHAHAM
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/16/2010
Decision Date 06/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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